Avastin Approved in Europe for First-line Treatment of Patients with Advanced Lung Cancer

Avastin Approved in Europe for First-line Treatment of Patients with Advanced Lung Cancer

August 24, 2007

First Medicine Shown to Extend Survival Beyond One Year in
Previously Untreated Lung Cancer Patients


    BASEL, Switzerland, Aug. 24 /Xinhua-PRNewswire/ --
Avastin (bevacizumab), Roche's innovative anti-cancer drug,
was approved today in Europe for the first-line treatment of
patients with advanced non-small cell lung cancer (NSCLC),
in combination with platinum-based chemotherapy.

    NSCLC is the most common form of lung cancer, a
difficult to treat disease that kills over 3,000 people per
day worldwide.(1) NSCLC is usually diagnosed at an advanced
stage, meaning individuals diagnosed with the disease
typically have a life expectancy of only 8 to 10
months.(2),(3) Avastin is the only first-line therapy to
demonstrate improved survival benefits beyond one year in
patients with advanced NSCLC.

    The approval is based on data from the pivotal US phase
III trial (E4599) and the 'Avastin in Lung' (AVAiL) phase
III trial. Both studies demonstrate that Avastin is
effective for the treatment of patients with NSCLC in
combination with platinum-based chemotherapy. The approval
is for the use of Avastin at a dose of 7.5 or 15 mg/kg, in
combination with platinum-based chemotherapy, for the
first-line treatment of patients with unresectable
advanced, metastatic or recurrent NSCLC other than
predominantly squamous cell histology. The broad label that
Avastin has received for the treatment of NSCLC allows the
combination of Avastin with any platinum-based chemotherapy
regimens (for example, together with taxanes or gemcitabine)
at the choice of the physician.

    Professor Christian Manegold, Professor of Medicine at
Heidelberg
University, University Medical Center Mannheim, Germany and
Principal Investigator of the AVAiL trial, was enthusiastic
about the news: "Lung cancer is an extremely difficult
disease to treat and Avastin has proven that it can prolong
the life of patients with NSCLC. A treatment like Avastin
that breaks through the one year survival barrier is a big
step forward. The European approval for Avastin means we
can reassess our expectations for lung cancer patient
survival."

    Avastin is the first and only anti-angiogenic agent
which has been shown to consistently deliver improved
overall and/or progression-free survival for patients with
colorectal, lung, breast and kidney cancer.

    About the Phase III studies that formed the basis of
the approval

    E4599 study

    The results of the randomised, controlled, multicentre
phase III E4599 study of 878 patients with locally
advanced, metastatic or recurrent NSCLC, with histology
other than predominant squamous cell, show that median
survival of patients treated with Avastin at a dose of 15
mg/kg every three weeks plus chemotherapy was 12.3 months,
compared to 10.3 months for patients treated with
chemotherapy alone. Patients receiving Avastin in
combination with paclitaxel and carboplatin had a 25%
improvement in overall survival compared to patients who
received chemotherapy alone. Side effects were generally
manageable. Pulmonary haemorrhage/ haemoptysis cases were
observed in 2.3% of the patients receiving Avastin plus
chemotherapy. The most common adverse events associated
with Avastin therapy were: hypertension (5.6%), proteinuria
(4.2%), fatigue (5.1%) and dyspnoea (5.6%).(4)

    AVAiL study

    In the double-blind, randomised, controlled, phase III
AVAiL study, patients received treatment with either
Avastin at 7.5mg/kg or 15mg/kg + cisplatin/gemcitabine or
placebo + cisplatin/gemcitabine. The study involved more
than 1,000 patients world-wide with previously untreated
advanced NSCLC, with histology other than predominant
squamous cell. The results show that by adding Avastin to a
cisplatin/gemcitabine regimen progression-free survival was
significantly prolonged by 20 to 30% compared with
chemotherapy alone. No new or unexpected adverse events
were observed.

    All trademarks used or mentioned in this release are
protected by law.

    Additional information
    -- Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

    -- Roche Health Kiosk, Cancer:
http://www.health-kiosk.ch/start_krebs

    -- Avastin: http://www.avastin-info.com

    To access video clips about Avastin, in broadcast
standard, free of charge, please go to:
http://www.thenewsmarket.com .

    References

    (1). Kamangar F, et al. Patterns of cancer incidence,
mortality, and prevalence across five continents: defining
priorities to reduce cancer disparities in different
geographic regions of the world. J Clin Oncol 2006;24(14):
2137-50.

    (2). Schiller JH, et al. Comparison of four
chemotherapy regimens for advanced non-small-cell lung
cancer. N Engl J Med 2002;346:92-8.

    (3). Sandler A, et al. Paclitaxel-Carboplatin Alone or
with Bevacizumab for Non-Small-Cell Lung Cancer. N Engl J
Med. 2006:355; 2542-50

    (4). Data on file. Roche, 2006





    




    For more information, please contact:

    Roche
     Erica Bersin 
     Email: [e-mail]

    Galliard Healthcare
     Dominic Elliston, 
     Tel:   [phone] (direct)
     Email: [e-mail]